FDA Product Code DWP: Dilator, Vessel, Surgical
Leading manufacturers include Shiley, Inc., Geomed Medizin-Technik GmbH & Co. and Fehling Surgical Instruments, Inc..
20
Total
20
Cleared
116d
Avg days
1979
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Dilator, Vessel, Surgical Devices (Product Code DWP)
20 devices
Cleared
Apr 20, 2023
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
Fehling Surgical Instruments, Inc.
Cardiovascular
381d
Cleared
Sep 03, 2019
Geomed Vascular Dilators
Geomed Medizin-Technik GmbH & Co.
Cardiovascular
265d
Cleared
Oct 16, 1990
FOGARTY VESSEL CALIBRATOR
Baxter Healthcare Corp
Cardiovascular
154d
Cleared
Aug 31, 1983
VESSEL DILATOR
Abbott Laboratories
Cardiovascular
29d
Cleared
Dec 04, 1979
BONCHEK-SHILEY VEIN DISTENTION SYSTEM
Shiley, Inc.
Cardiovascular
43d
Cleared
Jun 13, 1979
SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO
Shiley, Inc.
Cardiovascular
26d
About Product Code DWP - Regulatory Context
510(k) Submission Activity
20 total 510(k) submissions under product code DWP since 1979, with 20 receiving FDA clearance (average review time: 116 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.